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Sr. R&D Engineer, Systems - Shockwave Medical

Company: Disability Solutions
Location: Santa Clara
Posted on: February 8, 2025

Job Description:

Johnson & Johnson is hiring for a Sr. R&D Engineer, Systems - Shockwave Medical to join our team located in Santa Clara, CA.\rAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.\rFor more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges. We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.\rAt Johnson & Johnson, we all belong.\rShockwave Medical, Inc., recently acquired by Johnson & Johnson, is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Shockwave Medical aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.\rPosition OverviewThe Sr. R&D Engineer, Systems will work with cross-functional teams to develop and sustain products at Shockwave Medical that satisfy customer needs and drive business strategies. The Sr. R&D Engineer, Systems will engage in specification writing and development; test and report writing and development; execute testing; DHF maintenance; and provide support to other departments as required.\rEssential Job Functions

  • \r
  • Design and develop product(s) and documentation in full compliance with the company's Design Control requirements and consistent with FDA, ISO, and MDD criteria
  • Participate on cross-functional development teams that manage projects from concept through commercialization
  • Evaluate existing document architecture and assess gaps and dependencies
  • Work with stakeholders to establish project needs and functional group interfaces.
  • Work with on-market groups and data sets to assess device performance.
  • Support sustaining activities for on-market products
  • Support quality audits and follow-up activities.
  • Ensure lab notebooks are documented in a timely manner and consistent with the applicable SOP
  • Develop protocols/reports and perform product in-vitro, in-vivo verification and validation testing
  • Good written and verbal communication skills to convey complex concepts and approaches Provide support to operations and regulatory initiatives as required.
  • Other duties as needed.\r\r

Keywords: Disability Solutions, Santa Clara , Sr. R&D Engineer, Systems - Shockwave Medical, Healthcare , Santa Clara, California

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